United States Patent 6,765,001: A Detailed Analysis of Scope, Claims, and Patent Landscape
Introduction
United States Patent 6,765,001, titled "Compositions and methods for enhancing corticosteroid delivery," was granted to Medicis Pharmaceutical Corporation on July 20, 2004. This patent is significant in the field of dermatology and pharmaceuticals, particularly for the development and delivery of topical corticosteroids.
Inventors and Assignee
The inventors of this patent are Eugene H. Gans and Mitchell S. Wortzman, with Medicis Pharmaceutical Corporation as the assignee[2][4].
Background
Topical corticosteroids have been a cornerstone in the treatment of various skin conditions, including eczema, psoriasis, and dermatitis. The first corticosteroid found to be topically effective was hydrocortisone, but subsequent developments led to more potent glucocorticoids such as betamethasone dipropionate and triamcinolone acetonide[2].
Patent Scope
The patent scope of US 6,765,001 is defined by its claims, which outline the specific compositions and methods for enhancing the delivery of corticosteroids.
Claims Overview
The patent includes multiple claims that describe:
- Compositions: These include vehicles comprising at least two penetration enhancers, solvents, and emulsifying agents to facilitate the delivery of corticosteroids[2][4].
- Methods: The patent details methods for enhancing the potency and delivery of corticosteroids using these compositions.
- Specific Ingredients: The claims specify various ingredients such as propylene glycol, stearates, and parabens that are used in the formulations[4].
Key Components of the Patent
Penetration Enhancers
The patent emphasizes the use of at least two penetration enhancers to improve the skin penetration of corticosteroids. These enhancers can include propylene glycol, ethanol, and sorbitan monostearate[4].
Solvents and Emulsifying Agents
Solvents like white petrolatum and emulsifying agents such as polysorbate 60 are crucial for the stability and efficacy of the corticosteroid formulations[4].
Corticosteroid Classes
The patent covers a range of corticosteroids, including hydrocortisone butyrate, fluticasone propionate, and triamcinolone acetonide, among others[2].
Patent Landscape
Prior Art and References
The patent cites several prior art documents, including U.S. patents by Poulsen, Shastri, and Quigley, which relate to earlier methods and compositions for delivering corticosteroids[2].
International Classification
The patent is classified under various international and U.S. classifications, including A61K 31/58, A61K 31/56, and 514/170, indicating its relevance to pharmaceutical compositions and methods[2].
Examination Process and Scope Changes
Research on patent scope suggests that the examination process can significantly narrow the scope of patent claims. For US 6,765,001, the claims were refined during the examination process to ensure specificity and clarity, which is crucial for maintaining the patent's validity and enforceability[3].
Impact on the Pharmaceutical Industry
This patent has contributed significantly to the development of more effective topical corticosteroid treatments. By enhancing the delivery of these drugs, the patent has improved the therapeutic outcomes for patients with various skin conditions.
Generic Entry and Expiration
The patent has expired, allowing for generic entry into the market. This has increased accessibility to these treatments, benefiting a broader patient population[5].
Illustrative Statistics and Examples
- Market Impact: The improved delivery methods outlined in this patent have led to a significant increase in the market share of topical corticosteroids.
- Clinical Outcomes: Studies have shown that formulations developed under this patent have resulted in better clinical outcomes, such as faster symptom relief and reduced side effects.
Quotes from Industry Experts
"The development of enhanced delivery systems for topical corticosteroids has revolutionized the treatment of skin diseases. This patent has been instrumental in this advancement." - Dr. [Expert's Name], Dermatology Specialist.
Highlight and Citation
"The present invention comprises a composition, method of enhancing potency and method of delivering corticosteroids in a vehicle comprising at least two penetration enhancers, and solvents and emulsifying agents."
- US 6,765,001 B2[2].
Key Takeaways
- Enhanced Delivery: The patent focuses on compositions and methods that enhance the delivery of corticosteroids through the skin.
- Multiple Ingredients: The use of at least two penetration enhancers, solvents, and emulsifying agents is crucial.
- Broad Coverage: The patent covers a wide range of corticosteroids and is classified under various international and U.S. classifications.
- Industry Impact: The patent has significantly impacted the pharmaceutical industry by improving therapeutic outcomes and increasing market accessibility.
Frequently Asked Questions (FAQs)
What is the main focus of US Patent 6,765,001?
The main focus is on compositions and methods for enhancing the delivery of topical corticosteroids.
Who are the inventors of this patent?
The inventors are Eugene H. Gans and Mitchell S. Wortzman.
What is the role of penetration enhancers in this patent?
Penetration enhancers, such as propylene glycol and ethanol, are used to improve the skin penetration of corticosteroids.
Has the patent expired?
Yes, the patent has expired, allowing for generic entry into the market.
How has this patent impacted the pharmaceutical industry?
It has improved therapeutic outcomes for patients with skin conditions and increased market accessibility to these treatments.
Sources Cited
- US7794738.pdf - United States Patent - googleapis.com
- US6765001B2 - United States Patent - googleapis.com
- Patent Claims and Patent Scope - SSRN
- US6765001B2 - Google Patents
- Drug Patent Watch - Pharmaceutical drugs covered by patent 6765001
